Responsibilities: Execute the design and development of complex electro-mechanical medical devices and equipment Develop detail ed CAD design packages (3D data and 2D drawings) Maintain day-to-day communication with program managers and all appropria
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RESPONSIBILITIES: Ensures that postmarket surveillance tasks are completed as required by company policies and procedures, as well as compliance with applicable industry regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485-2003,
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Responsibilities: Recruit, manage, develop and mentor regulatory affairs professionals. Work with regulatory associates, determine submission and approval..